Journal
PEDIATRIC BLOOD & CANCER
Volume 68, Issue 10, Pages -Publisher
WILEY
DOI: 10.1002/pbc.29169
Keywords
asparaginase Erwinia chrysanthemi shortages; asparaginase hypersensitivity; JZP-458; pharmacokinetics; recombinant technology; serum asparaginase activity
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Funding
- Jazz Pharmaceuticals
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Acute lymphoblastic leukemia is the most common childhood cancer, with asparaginase playing a crucial role in treatment, but hypersensitivity reactions to certain types limit their use. JZP-458, a recombinant Erwinia asparaginase, offers a potential alternative for patients with hypersensitivity to ensure continued availability of treatment options.
Acute lymphoblastic leukemia (ALL) is the most common childhood cancer. Bacterial L-asparaginase has played an important role in ALL treatment for several decades; however, hypersensitivity reactions to Escherichia coli-derived asparaginases often preclude their use. Inability to receive asparaginase due to hypersensitivities is associated with poor patient outcomes. Erwinia chrysanthemi-derived asparaginase (ERW) is an effective, non-cross-reactive treatment option, but is limited in supply. Consequently, alternative asparaginase preparations are needed to ensure asparaginase availability for patients with hypersensitivities. Recombinant technology can potentially address this unmet need by programming cells to produce recombinant asparaginase. JZP-458, a recombinant Erwinia asparaginase derived from a novel Pseudomonas fluorescens expression platform with no immunologic cross-reactivity to E. coli-derived asparaginases, has the same primary amino acid sequence as ERW, with comparable activity based on in vitro measurements. The efficient manufacturing of JZP-458 would provide an additional asparaginase preparation for patients with hypersensitivities.
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